| CTRI Number |
CTRI/2024/08/071913 [Registered on: 05/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of premenstrual disorder on sleep, physical activity and academic performance |
|
Scientific Title of Study
|
Association of Premenstrual Syndrome with Sleep, Physical Activity and its effect on Academic Performance: A Cross- Sectional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandni Mahant |
| Designation |
BPT Student |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar Medical College and Hospital, Department of Physiotherapy, Room no. 510 Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8091711073 |
| Fax |
|
| Email |
mahantc88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Kumar PT |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar Medical College and Hospital, Department of Physiotherapy, Room no. 510, Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
7807125689 |
| Fax |
|
| Email |
tomarankit084@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Mehra |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar Medical College and Hospital, Department of Physiotherapy, Room no. 510, Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
9896644741 |
| Fax |
|
| Email |
mehra.drpooja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan-173229, Himachal Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Chandni Mahant |
| Address |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan, Himachal Pradesh |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Chandni Mahant |
Maharshi Markandeshwar College and Hospital, Kumarhatti, Solan |
Department of Orthopedic, Physiotherapy Department, Room no. 510
Solan
HIMACHAL PRADESH |
8091711073
mahantc88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MM Medical College Kumarhatti Solan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Premenstrual Syndrome |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1.Symptoms of PMS
2.Regular Menstrual Cycle
3.Nulliparous Women
|
|
| ExclusionCriteria |
| Details |
1.Amenorrhea for more than 3 months
2.Presence of gynecological and psychiatric disorder
3.Current pregnancy or child birth
4.Disease like DM, Hypertension, Migraine, Epilepsy, Anemia, Thyroid Disorders, ovarian disease
5.Use of oral contraceptives or anti-depressant drugs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Shortened Premenstrual Assessment Form
2. Sleep Quality Scale (SQS)
3. International Physical Activity Questionnaire Short Form (IPAQ-SF)
4.Acedemic Performance Questionnaire for Premenstrual Syndrome (APQPS) |
one time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="340"
Sample Size from India="340"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Premenstrual syndrome (PMS) is combination of emotional,
behavioral and physical symptoms occur in luteal phase of menstrual cycle that
starts on the 14th day of menstrual cycle and causes premenstrual
symptoms which subsides within the onset of flow. Its impacts the sleep
quality, physical activity and academic performance. The global prevalence of PMS is reported as 47.8%. In India, estimates the PMS
prevalence have varied from 14.3% to 74.4%. PMDD affects 3% to 8% of women. The purpose of the study
is to investigate the association of premenstrual syndrome with sleep
disturbance, physical activity and its effect on academic performance among
college going females. |